{"id":"bff-mdi-pt009","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Nasopharyngitis"}]},"_chembl":{"chemblId":"CHEMBL1588467","moleculeType":"Small molecule","molecularWeight":"332.31"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PT009 combines an inhaled corticosteroid (budesonide) to reduce inflammation, a long-acting beta-2 agonist (formoterol) for bronchodilation, and a long-acting muscarinic antagonist (glycopyrronium) for additional airway relaxation. This triple-therapy approach addresses multiple pathways in COPD pathophysiology through a single maintenance inhaler device.","oneSentence":"BFF MDI is a combination inhaled therapy containing budesonide, formoterol, and glycopyrronium that reduces airway inflammation and improves bronchodilation in chronic obstructive pulmonary disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:04:08.542Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic obstructive pulmonary disease (COPD) maintenance therapy"}]},"trialDetails":[{"nctId":"NCT04609878","phase":"PHASE3","title":"Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2020-12-15","conditions":"Asthma","enrollment":2274},{"nctId":"NCT04609904","phase":"PHASE3","title":"Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2021-03-01","conditions":"Asthma","enrollment":2187},{"nctId":"NCT02536508","phase":"PHASE3","title":"Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2015-08-10","conditions":"COPD","enrollment":627},{"nctId":"NCT02465567","phase":"PHASE3","title":"Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2015-06-30","conditions":"COPD","enrollment":8588},{"nctId":"NCT02497001","phase":"PHASE3","title":"A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos)","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2015-08-10","conditions":"COPD","enrollment":1902},{"nctId":"NCT03262012","phase":"PHASE3","title":"Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With COPD Compared With Symbicort® Turbohaler®","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2016-08-09","conditions":"COPD","enrollment":416},{"nctId":"NCT02727660","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2016-04-29","conditions":"Chronic Obstructive Pulmonary Disorder","enrollment":1876},{"nctId":"NCT02766608","phase":"PHASE3","title":"Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2016-05-31","conditions":"Chronic Obstructive Pulmonary Disorder","enrollment":2389},{"nctId":"NCT03081247","phase":"PHASE3","title":"To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease","status":"WITHDRAWN","sponsor":"Pearl Therapeutics, Inc.","startDate":"2018-04-16","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":""},{"nctId":"NCT02196077","phase":"PHASE2","title":"Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2014-08-01","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":180}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["BFF"],"phase":"phase_3","status":"active","brandName":"BFF MDI (PT009)","genericName":"BFF MDI (PT009)","companyName":"Pearl Therapeutics, Inc.","companyId":"pearl-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BFF MDI (PT009) is a small molecule medication used to treat Chronic Obstructive Pulmonary Disease (COPD). It is administered via a metered-dose inhaler (MDI) in various formulations, including BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg, and BGF MDI 160/14.4/9.6 μg.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}